NCT05423665 Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth Twin Pregnancies
| NCT ID | NCT05423665 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Fetal Growth Restriction |
| Study Type | OBSERVATIONAL |
| Enrollment | 360 participants |
| Start Date | 2023-06-22 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 360 participants in total. It began in 2023-06-22 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this project there are 2 time points during the pregnancy included, namely at 21 weeks and 30 weeks of gestation, to measure the predictive values of FGR, strain and strain rate. The fetal growth parameters will be collected at the same time points, to define the growth (differences) throughout gestation of both fetuses. A maternal blood sample will be taken at 21 weeks of gestation to identify the level of exposure to air pollution (black carbon) and the level of biochemical markers of placental dysfunction. Doppler ultrasounds will be used for antenatal identification of placenta insufficiency. At birth, umbilical cord blood and the placenta will be collected. The placenta will be examined, to identify morphological findings which are associated with FGR. The umbilical cord blood and placental biopsy will be used for the level of exposure to air pollution and the level of oxidative stress. One to three days after birth, neonatal strain and strain rate will be measured to define postnatal cardiac remodeling as well as the neonatal blood pressure as cardiovascular risk factor.
Eligibility Criteria
Inclusion Criteria: * Singleton or dichorionic twin pregnancy * Pregnant women 21 weeks ( ± 2 weeks) of gestation at the first visit * Women ≥ 18 years Exclusion Criteria: * Women pregnant of multiples of higher order (≥3 siblings) Monochorionic twin pregnancy * Fetal arrhythmia * Known fetal congenital or genetic abnormalities * Any suspicion of congenital fetal anomalies that might influence fetal cardiac function * Pre-existing maternal hypertensive disease * Autoimmune disease including systemic lupus erythematosus * History of stillbirth * Diabetes mellitus (mother)
Contact & Investigator
Kristien Roelens
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT05423665 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Fetal Growth Restriction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05423665 currently recruiting?
Yes, NCT05423665 is actively recruiting participants. Contact the research team at eline.meireson@uzgent.be for enrollment information.
Where is the NCT05423665 trial being conducted?
This trial is being conducted at Ghent, Belgium, Leuven, Belgium, Eindhoven, Netherlands.
Who is sponsoring the NCT05423665 clinical trial?
NCT05423665 is sponsored by University Hospital, Ghent. The principal investigator is Kristien Roelens at University Hospital, Ghent. The trial plans to enroll 360 participants.